1. Field of the Invention
The present invention relates to the analysis of pharmaceutical and pharmaceutical-like products. More particularly, the present invention relates to an apparatus and process for analyzing and/or predicting the release of active agents in pharmaceutical and pharmaceutical-like products.
2. Description of Related Art
Contemporary dissolution devices include a basket-type, a paddle-type and a reciprocating cylinder-type. For example, the contemporary paddle type dissolution apparatus has a glass, round-bottomed vessel with an impeller mixing the contents of the vessel. The apparatus can also have an auto-sampler shaft inserted into the vessel to collect samples at selected intervals of time from an aqueous solution in the vessel. A tablet to be analyzed is dropped into the vessel and falls to the bottom of the vessel, where it sits during the dissolution run. The basket and reciprocating cylinder-type dissolution devices similarly provide for mixing of the solution in the device while the tablet rests in the vessel.
These contemporary dissolution devices were designed for quality control of drug release rates. The contemporary dissolution devices suffer from the drawback of failing to adequately replicate the conditions that a dosage form encounters in the gastro-intestinal (GI) tract, e.g., the stomach and/or intestine. None of these contemporary devices simulate or account for the forces applied to the dosage form due to the digestive conditions and peristaltic actions along the GI tract.
As shown in FIG. 1, food and liquids are present in the GI tract, in addition to digestive muscular contractions, mass movement, compression, peristalsis, and other forces. All of these conditions can play a key role in the rate of drug release, especially for controlled or extended release products. These mechanically destructive forces are clearly present and are imparted on a dosage form as it travels along the GI tract.
Accordingly, there is a need for an apparatus and process for analyzing and predicting the release of active pharmaceutical ingredients (API) or active agents from pharmaceutical and pharmaceutical-like products. There is a further need for such an apparatus and process that more adequately replicates or simulates the conditions in the GI tract.